BRAVO-3 Trial Shows Increased Risk of Early Stroke With New-Onset Atrial Fibrillation After TAVR
May 11, 2017—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the presentation of data from the BRAVO-3 randomized trial showing that more than one-third of patients undergoing transcatheter aortic valve replacement (TAVR) had atrial fibrillation (AF) either at baseline or new-onset AF within 30 days after TAVR. Patients with new-onset AF had a more than fourfold greater risk of stroke within 30 days.
Findings from the BRAVO-3 study on the effect of bivalirudin (BIV) versus unfractionated heparin (UFH) in patients with baseline or new-onset AF in TAVR were presented by Principal Investigator George D. Dangas, MD, as a late-breaking clinical trial at the SCAI 2017 scientific sessions in New Orleans, Louisiana.
According to SCAI, the BRAVO-3 trial randomized 802 patients (mean age, 82 years) to BIV or UFH for transfemoral TAVR. In this substudy, 41.4% (n = 332) of patients had baseline AF or new-onset AF within 30 days of TAVR, and 58.6% (n = 470) had no AF. Patients with existing or new AF had a greater occurrence of preexisting comorbidities, including renal dysfunction, lower left ventricular ejection fraction, and a higher EuroSCORE I.
In the SCAI announcement, Dr. Dangas commented, “Previous studies have shown that AF patients undergoing TAVR have a greater risk for ischemic, as well as bleeding, events.” Dr. Dangas is Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of Cardiovascular Innovation at the Zena and Michael A. Weiner Cardiovascular Institute of the Mount Sinai Medical Health System in New York, New York.
“We wanted to study these associations using a more contemporary population, in the context of overall improved devices, techniques, and post-TAVR management to see if the results were similar. We were also interested in studying the antithrombotic prescription patterns in this high-risk patient population, as there is currently no consensus on the optimal strategy following TAVR.”
The primary endpoint of the BRAVO-3 trial was 48-hour Bleeding Academic Research Consortium (BARC) type 3b bleeding. For this substudy, the two main outcomes of interest were stroke and death at 30 days in patients with AF versus patients with no AF. Outcomes were also examined by treatment with BIV or UFH.
Unadjusted 30-day clinical outcomes for AF patients were stroke (3.9%), death (6%), and BARC major bleeding (10.2%). Outcomes for non-AF patients were stroke (2.6%), death (4.5%), and BARC major bleeding (9.4%). The unadjusted odds of early stroke in patients with new-onset AF were 4.49 times greater compared to odds in patients with no AF. No significant differences were noted in 30-day outcomes by AF status and anticoagulant strategy.
Study investigator Usman Baber, MD, explained, “Our study showed that a large percentage of patients have AF, either baseline or new onset. New-onset AF lends a significantly higher risk of early stroke, nearly fivefold. Moreover, although nearly all AF patients had a high calculated predictive stroke risk score (CHA2DS2VASc) of ≥ 4, we found that only over half went home on an oral anticoagulant. We need to better risk stratify AF patients during follow-up, when acute risk of bleeding has abated, for prescription of anticoagulants where appropriate.” Dr. Baber is Assistant Professor of Medicine and Cardiology at Icahn School of Medicine at Mount Sinai.